FDA Adverse Event
Injury
Summary report: N
RELIA S
MDR report key: 6007661
·
Received October 6, 2016
Report
- Report Number
- 9614453-2016-06197
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- August 6, 2016
- Report Date
- August 6, 2016
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD FAINTED FOUR TIMES AND THE DEVICE WAS NOTED IN ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONALLY, THE LEAD HAD DISLODGED SHOWING HIGH THRESHOLD. THE LEAD AND DEVICE WERE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660657 | RELIA S | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | RES01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening | 5076-58 |